抗结核固定剂量复合剂治疗药物敏感肺结核的安全性和有效性

doi:10.19982/j.issn.1000-6621.20260253

中国防痨杂志 ›› 2026, Vol. 48 ›› Issue (8): 1158-1162.doi: 10.19982/j.issn.1000-6621.20260253

抗结核固定剂量复合剂治疗药物敏感肺结核的安全性和有效性

李信达¹, 侯志丽², 欧阳兵³, 杜亚东⁴, 关丽英⁵, 于红梅⁶, 张海芹⁷, 谢勇杰⁸, 唐佩军⁹, 肖雨¹⁰, 张瑛¹¹, 陆宇¹()

¹ 首都医科大学附属北京胸科医院/北京市结核病胸部肿瘤研究所药物学研究室, 北京 101149
² 天津市海河医院结核病科, 天津 300350
³ 昆明市第三人民医院结核病科, 昆明 650041
⁴ 首都医科大学附属北京胸科医院结核一科, 北京 101149
⁵ 内蒙古自治区第四医院感染科, 呼和浩特 010030
⁶ 长春市传染病医院结核病科, 长春 130028
⁷ 内蒙古自治区包头市第三医院结核感染科, 包头 014040
⁸ 湖南省胸科医院综合门诊部, 长沙 410013
⁹ 苏州市第五人民医院结核病科, 苏州 215131
¹⁰ 安徽省胸科医院结核科, 合肥 230022
¹¹ 湖南省益阳市第四人民医院肺病诊疗中心, 益阳 413000

收稿日期:2026-05-05 出版日期:2026-08-01 发布日期:2026-07-30
通信作者: 陆宇,Email:luyu4876@hotmail.com

Evaluation of safety and efficacy of anti-tuberculosis fixed-dose combination in patients with drug-susceptible pulmonary tuberculosis

Li Xinda¹, Hou Zhili², Ouyang Bing³, Du Yadong⁴, Guan Liying⁵, Yu Hongmei⁶, Zhang Haiqin⁷, Xie Yongjie⁸, Tang Peijun⁹, Xiao Yu¹⁰, Zhang Ying¹¹, Lu Yu¹()

¹ Department of Pharmacology, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China
² Department of Tuberculosis, Tianjin Haihe Hospital, Tianjin 300350, China
³ Department of Tuberculosis, Kunming Third People’s Hospital, Kunming 650041, China
⁴ First Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing 101149, China
⁵ Department of Infectious Diseases, Fourth Hospital of Inner Mongolia Autonomous Region, Hohhot 010030, China
⁶ Department of Tuberculosis, Changchun Infectious Disease Hospital, Changchun 130028, China
⁷ Department of Tuberculosis Infection, Baotou Third Hospital, Inner Mongolia Autonomous Region, Baotou 014040, China
⁸ General Outpatient Department, Hunan Chest Hospital, Changsha 410013, China
⁹ Department of Tuberculosis, Suzhou Fifth People’s Hospital, Suzhou 215131, China
¹⁰ Department of Tuberculosis, Anhui Chest Hospital, Hefei 230022, China
¹¹ Pulmonary Disease Diagnosis and Treatment Center, Yiyang Fourth People’s Hospital, Hunan Province, Yiyang 413000, China

Received:2026-05-05 Online:2026-08-01 Published:2026-07-30
Contact: Lu Yu, Email: luyu4876@hotmail.com

摘要/Abstract

摘要：

目的: 通过真实世界研究评估抗结核固定剂量复合剂(fixed-dose combination,FDC)治疗药物敏感肺结核的安全性和有效性。方法: 采用单臂队列前瞻性研究设计,于2024年9月至2025年9月期间在首都医科大学附属北京胸科医院等全国10家省、市级结核病定点医院纳入305例药物敏感肺结核患者,进行抗结核FDC治疗(强化期:乙胺吡嗪利福异烟片,2个月;巩固期:异福片/异福胶囊,4个月);随访6个月评估其疗效和安全性。疗效指标包括:痰菌阴转率、药物敏感性、病灶吸收及空洞变化情况;安全性指标包括:肝肾功能、血常规、尿常规及不良事件发生情况等。结果: 研究对象抗结核FDC治疗6个月时痰菌阴转率为98.7%(150/152);肺部影像学数据显示180例(59.0%)病灶明显吸收,79例(25.9%)病灶吸收,156例(51.1%)空洞闭合,88例(28.9%)空洞缩小;治疗成功率为91.1%(278/305)。研究对象共计出现219次不良事件,其中,Ⅰ级203次、Ⅱ级10次、Ⅲ级5次,1例死亡(脑瘤所致,与治疗药物无关);发生的不良事件主要包括胃肠道不良反应27次(8.9%,27/305),转氨酶、总胆红素升高33次(10.8%, 33/305)及高尿酸血症111次(36.4%,111/305)。结论: 抗结核FDC治疗药物敏感肺结核具有良好的有效性、安全性和治疗完成率。

关键词: 结核,肺, 抗结核药, 固定剂量复合剂, 治疗结果, 评价研究

Abstract:

Objective: To evaluate the safety and efficacy of anti-tuberculosis fixed-dose combination (FDC) in the treatment of drug-susceptible pulmonary tuberculosis via a real-world study. Methods: A single-arm prospective cohort design was adopted. A total of 305 patients with drug-susceptible pulmonary tuberculosis were enrolled from September 2024 to September 2025 at 10 provincial and municipal designated tuberculosis hospitals nationwide including Beijing Chest Hospital, Capital Medical University. All patients received anti-tuberculosis FDC therapy: ethambutol hydrochloride, pyrazinamide, rifampicin and isoniazid tablets for a 2-month intensive phase, followed by rifampinand isoniazid tablets/capsules for a 4-month continuation phase. A 6-month follow-up was conducted to assess efficacy and safety. Efficacy indicators included sputum culture conversion rate, drug susceptibility, lung lesion absorption and cavity changes. Safety indicators covered liver and renal function, blood routine, urine routine and the incidence of adverse events. Results: The sputum conversion rate reached 98.7% (150/152) after 6 months of FDC treatment. Pulmonary imaging results revealed marked lesion absorption in 180 patients (59.0%) and partial lesion absorption in 79 patients (25.9%); cavities were closed in 156 patients (51.1%) and shrunk in 88 patients (28.9%). The overall treatment success rate was 91.1% (278/305). A total of 219 adverse events were recorded, among which 203 were Grade Ⅰ, 10 Grade Ⅱ and 5 Grade Ⅲ. One death occurred due to brain tumor, which was unrelated to anti-tuberculosis drugs. The predominant adverse events included 27 (8.9%, 27/305) gastrointestinal adverse reactions, 33 (10.8%, 33/305) cases of elevated transaminases and total bilirubin, and 111 (36.4%, 111/305) cases of hyperuricemia. Conclusion: Anti-tuberculosis FDC demonstrates favorable efficacy, safety and treatment completion rate for drug-susceptible pulmonary tuberculosis.

Key words: Tuberculosis, pulmonary, Antitubercular agents, Fixed-dose combination, Treatment outcome, Evaluation studies

中图分类号:

李信达, 侯志丽, 欧阳兵, 杜亚东, 关丽英, 于红梅, 张海芹, 谢勇杰, 唐佩军, 肖雨, 张瑛, 陆宇. 抗结核固定剂量复合剂治疗药物敏感肺结核的安全性和有效性[J]. 中国防痨杂志, 2026, 48(8): 1158-1162. doi: 10.19982/j.issn.1000-6621.20260253

Li Xinda, Hou Zhili, Ouyang Bing, Du Yadong, Guan Liying, Yu Hongmei, Zhang Haiqin, Xie Yongjie, Tang Peijun, Xiao Yu, Zhang Ying, Lu Yu. Evaluation of safety and efficacy of anti-tuberculosis fixed-dose combination in patients with drug-susceptible pulmonary tuberculosis[J]. Chinese Journal of Antituberculosis, 2026, 48(8): 1158-1162. doi: 10.19982/j.issn.1000-6621.20260253

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抗结核固定剂量复合剂治疗药物敏感肺结核的安全性和有效性

Evaluation of safety and efficacy of anti-tuberculosis fixed-dose combination in patients with drug-susceptible pulmonary tuberculosis

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